Limited use tool disposable enclosure

ABSTRACT

A re-usable medical procedure power tool includes a subframe having a handle portion connected to a tool attachment portion and a power source portion. A removable, single use, contamination-blocking cover substantially covers the sub frame of the tool. At least the handle portion of the cover includes a flexible portion providing a tactile feel portion for a user. The tactile feel portion is movable sufficient to move an associated trigger attached to the subframe.

This is a Divisional of Non-Provisional application Ser. No. 14/551,080filed Nov. 24, 2014, which is related to and claims priority toProvisional Application No. 61/913,266 filed Dec. 7, 2013.

BACKGROUND

This disclosure relates generally to limited use power tools and moreparticularly to an enclosure for such tools during use in medicalprocedures; the enclosure being removed and discarded duringreprocessing of the tools for subsequent re-use.

Important factors for any surgical instrument include sterility, cost ofacquisition, maintenance, and reliability during use in the surgicalsuite. Each of these factors can have a significant impact on the costof medical care for both the patient and the provider.

In recent years, there has been significant focus on the ever increasingcost of medical care. These cost increases have led to skyrocketinginsurance premiums, reduced coverage, reduced reimbursements, increasedfees for services, severe reductions in services for some patient groupsby some providers, and unfortunately an apparent increase in infectionsand medical mishaps.

In an effort to reduce costs and improve profitability, both serviceproviders and medical device suppliers are continuously looking for waysto streamline procedures, reduce time, cost, and risk from theirproducts and services without reducing the quality of the products orservices they provide to their customers. One area to benefit from thesesavings and improvements has been in the orthopedic surgical fieldthrough the use of high precision, battery powered surgicalinstrumentation. In the late 1960's and early 1970's battery operateddrills were bulky, ill-balanced and required multiple batteries toperform some surgeries due to the limited energy storage capacity andpoor efficiency of the electric motors.

Since then, manufacturers have attempted to make batteries moreefficient with higher energy storage capacity, reduced size, andimproved rechargeable lifespans. Likewise, motor housings such as sawand drill bodies have become more ergonomic, balanced, lightweight andenergy efficient. As with many standard hand tools having multiplemoving components, instrument manufacturers have reduced weight byutilizing lighter materials such as plastic housings, and gears, and putweight reducing apertures in what were previously solid housings. Insome cases, standard mountings for attachments have been replaced withmodular fittings, allowing for greater interchangeability and componentselections. Additionally, manufacturers have attempted to improveelectrical components by upgrading them with more modern componentswherever possible.

All of these improvements in equipment construction have improvedefficiencies, costs and quality in some areas while at the same timeincreasing costs for acquisition, maintenance and increasing risks inother ways that were not previously seen or predicted. Often times costand quality can be inversely proportional to one another. One example ofthe increased cost and patient risk is seen in the cleaning andmaintenance of instruments.

Recent published reports suggest that many of the surgical instrumentsused in operations were not being cleaned and/or sterilizedappropriately in the very hospital facilities that were established andtasked for that purpose. In numerous reports, following cleaning andsterilization, it was noted that upon closer secondary inspection, theinside of small diameter cannulas and intricate mini-components ofarthroscopic shavers that are used for many of today's minimallyinvasive procedures, contained human tissue and bone fragments fromprevious surgeries. In other cases, modular components of drills andsaws such as chucks, drill bits and blades were found to have similardebris or pieces of cleaning brushes and/or bristles embedded in or onthem. These investigations have demonstrated that in most cases theinstruments were not cleaned according to manufacturer's specificationswhich has likely lead to many documented cases of serious, multiple,serial infections for subsequent patients. A pilot program conducted bythe Centers for Medicare and Medicaid Services (Schaefer et al., 2010;JAMA 2010; 303(22):2273-2279) inspected 1500 outpatient surgery centersand found that 28% had been cited for infectious control deficienciesassociated with equipment cleaning and sterilization. The costs to thepatients and the hospitals in both expense and liability to deal withthese infections can be and has been staggering.

In other cases, critical battery-operated, motorized tools such asdrills or bone saws have ceased to function due to dead batteries thatno longer maintain their capacity to hold a charge, or due to internalpart failure, often attributable to overuse or lack of propermaintenance. The resultant downtime in the operating suite is extremelycostly, as the procedure step must be put on hold while replacement orsubstitute tools are obtained. Wait times may often exceed 20-30minutes, resulting in additional anesthesia exposure for the patient,additional operating room time (charged to the patient) and potentialdelays to other procedures where the replacement or substitute equipmenthad been scheduled for use in a later procedure. Recent estimates (2005)establish the average cost of operating room time to range between$62/min. (range $21.80-$133.12) depending on the procedure. Thesefigures did not include extra resources provided by the hospital forspecial, non-routine situations which often occur during standardprocedures, and did not include the surgeon and anesthesia providerfees, (anesthesia fees are estimated to be $4/min; range $2.20-$6.10).

Hospitals and instrument manufacturers are continuously attempting tofind improved ways to reduce risk associated with infection in general,and more recently, specifically from improperly cleaned instruments. Oneapproach has been to use more disposable, single-use instruments such asdrills, saw blades and plastic cannulas. Additionally, many laparoscopicdevices such as, surgical staplers and trocars, are designed as singleuse items that are intended to be immediately disposed of after use.Unfortunately, at today's acquisition costs, the total cost of ownershipand benefits are not always clear for high-use battery-operated,motorized instruments such as saws, drills and reamers used inorthopedic procedures and the idea of disposable powered instruments hasnot been readily embraced.

A recent trend in the medical community is reprocessing of single usemedical instruments, by parties other than the original equipmentmanufacturer, instead of discarding them after use. During reprocessing,the medical instruments are disassembled, cleaned and sterilized. Theyare then reassembled for future use. However, because the medicalinstruments reprocessed for further use are specifically provided foruse during a single procedure, the performance of the medicalinstruments tends to decline after reprocessing, because the componentsmaking up the medical instrument are not adapted for multiple uses andwill degrade in performance when used beyond their intended life span.For example, reprocessing of the cutting devices on trocars is intendedto extend these devices beyond their intended mission life, but oftenresults in duller cutting edges on the blades because neither thematerials used nor the reprocessing method can restore the device to theoriginal manufacturing specifications. A greater force, therefore, isneeded to make an initial incision, causing more trauma to the patient.In addition, the use of greater force increases the potential for errorduring the surgical procedure.

Most hospitals and surgery centers buy high-use, reusable motorized,pneumatic, wired or battery operated, orthopedic surgical equipment andare expected to clean, sterilize, and maintain them internally withinthe hospital. Unfortunately, the technicians hired to perform this workare typically not qualified or trained to perform this work adequatelyfor the many varieties of powered instruments used. Further,manufacturers rarely provide the hospital/client with the training ordiagnostic equipment necessary to evaluate or test the equipment. Oftentimes the hospital employees responsible for cleaning and maintenanceare not technicians at all, being paid slightly more than minimum wage,working at a fast pace to merely wash, count, and reload instrumentsinto their appropriate system trays and flash sterilize them as quicklyas possible, in an effort to keep the equipment in rotation in thehospital operating rooms, where higher throughput dictates profitabilityfor the hospital or surgery center.

As a result of high throughput requirements, general maintenance israrely done and preventative monitoring and maintenance is almost neverdone on this type of equipment. Hospital budgets for internalmaintenance of equipment are generally geared toward high-end,multi-million dollar capital equipment such as x-ray and radiologicalequipment. It is generally assumed that it is faster, simpler, and moreeconomical for the hospital to wait for hand-held instruments, such asdrills, saws and reamers to fail, then, send them back to themanufacturer for repair or replacement.

Thus it has become apparent that there is a need for an improved systemof cost-effective, battery-operated, motorized tools in conjunction withbetter cleaning and maintenance protocols which can provide thehospital, surgeon, and most importantly, the patient, with a higherdegree of efficiency and cleanliness while reducing risk and keeping thecosts of cleaning, maintenance, and repair as low as possible.

SUMMARY

Accordingly, a reusable medical procedure power tool comprises asubframe and a removable, single use contamination blocking toolattachment cover substantially covering the subframe of the power tool,wherein the power tool includes a tool attachment portion, a handleportion and a power source portion. At least the handle portion of thecover includes a flexible portion providing a tactile feel portion for auser. The tactile feel portion is movable sufficient to move anassociated trigger attached to the subframe.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective, assembly view illustrating an embodiment of apower tool having a housing and a removable, single use, hardshell orsoftshell wrap or cover formed of a contamination blocking material.

FIG. 2 is a perspective assembly view illustrating an embodiment of thepower tool of FIG. 1 wherein the cover is a stretch membrane.

FIGS. 3a and 3b are perspective assembly views illustrating embodimentsof the power tool of FIG. 1 wherein the covers include a shrink-wraptape and a shrink-wrap tube respectively.

FIG. 4 is a perspective assembly view illustrating an embodiment of amechanical sub-frame of a power tool having no housing and wherein thecover is a disposable hardshell.

FIG. 5 is a perspective assembly view illustrating an embodiment of thepower tool of FIG. 1 wherein the cover is spray-on applied.

FIG. 6 is a perspective assembly view illustrating an embodiment of thepower tool of FIG. 1 wherein the cover is dip applied.

FIG. 7 is a perspective assembly view illustrating an embodiment of thepower tool of FIG. 1 wherein the cover is a header bag.

FIG. 8 is a perspective assembly view illustrating an embodiment of thepower tool of FIG. 1 wherein the cover is a pre-cut wrap.

FIG. 9 is a perspective assembly view illustrating an embodiment of thepower tool of FIG. 1 wherein the cover is double layer stretch membrane.

FIG. 10 is a perspective view illustrating an embodiment of the powertool housing as viewed from the backside of the tool and having asealable door removed to expose a cavity to receive a portable battery.

FIG. 11 is a perspective view illustrating the tool of FIG. 10 havingthe sealable door installed.

FIG. 12 is a perspective view illustrating an embodiment of a sterilizedshipping tray and lid containing the power tool.

DETAILED DESCRIPTION

The embodiment of FIG. 1 illustrates an exemplary power tool 10 for usein medical procedures such as surgical procedures. A removable, singleuse, contamination-blocking cover 12 is provided for blocking excessivecontamination of the power tool 10 during use. The cover 12 isreplaceable, e.g. after the procedure, the cover 12 may be removed andreplaced by a new cover 12.

The tool 10 includes a housing 14 comprising a handle portion 16 and inthis example, a power source portion such as a receiver 18 for aportable battery pack and a tool attachment portion 20 having a chuck 21provided for releasably receiving and holding an attachment tool such asa drill bit or a saw blade. The handle 16 includes a control portionincluding but not limited to an actuating trigger 22, a trigger lock 24and a forward-reverse switch, all of which may not be visible in FIG. 1.The attachment point of a saw blade may vary depending on whether it isa reciprocating or oscillating blade.

The cover 12 preferably includes a two-piece hard or soft outer shellincluding portions 12 a and 12 b. The tool 10 is illustrated at 10 aprior to application of the cover 12, and is illustrated at 10 b afterapplication of the cover 12. A first opening 12 c is provided in cover12 adjacent chuck 21 when the cover is applied to the tool 10. A secondopening 12 d, which may be closed by a sealable door 19, is provided inpower source portion 18. Regardless of the material used for the cover12, a flexible portion 12 e of the cover 12 is provided on the handle 16to provide a user with a tactile feel and operable movement of forexample, the trigger 22 and the trigger lock 24.

The replaceable cover 12 is applied to tool 10 by a tool re-processor.Once the tool 10 is used in a procedure, the cover has becomecontaminated along with portions of the tool 10 which are adjacent theopenings 12 c, 12 d. The tool 10, including cover 12, is returned to thetool re-processor where the cover 12 is removed and discarded. The tool10 is then cleaned and a new cover 12 is mounted on the tool 10,rendering the tool 10 ready for re-use.

More specific information regarding the tool 10 and cover 12 of the FIG.1 embodiment as described above are set forth below as follows:

a. Existing product or new product uses a rigid body mechanical housing14 in conjunction with either a hard or soft/flexible shell outer shield12 that covers and protects the majority of the tool 10 fromcontamination by blood/bone/tissue during a procedure. Combinations ofmaterials such as a hard shell with flexible inserted areas for controlsactuation are also contained in this area. Additional reinforcements orseals can be used in high stress areas.

-   -   i. Materials and alloys/laminates of these materials appropriate        for this concept include but are not limited to:        -   a. PETG & A/PET        -   b. Polystyrene        -   c. Acrylic        -   d. Polycarbonate        -   e. ABS        -   f. Nylon        -   g. Polyolefin        -   h. Polyetheretherketone PEEK        -   i. Polyetherimide PEI        -   j. Polyetersulfone PES        -   k. Polyvinylidene PVDF        -   l. Polymethylpentene PMP        -   m. Polysulfone PSO        -   n. Ethylene-chlorotrifluoroethylene ECTFE        -   o. Metals    -   ii. Soft/flexible outer shell can be produced using injection        molding, thermoforming, dip molding, compression molding or        other processes. Materials and alloys of these materials        appropriate for this concept include but are not limited to:        -   a. Synthetic Paper        -   b. C-Flex        -   c. Flexible PVC        -   d. Polycarbonate        -   e. Polyester        -   f. Polyethylene        -   g. Polypropylene        -   h. Nylon        -   i. Polyolefin

b. Methods appropriate for fastening the outer shell to/around the innerstructure include but are not limited to:

-   -   i. Fasteners such as:        -   1. Screws        -   2. Rivets        -   3. Bolts    -   ii. Molded features such as:        -   1. Clips        -   2. Press fits        -   3. Slip fits    -   iii. Adhesive in multiple forms        -   1. Tape        -   2. Glue        -   3. Pressure sensitive adhesive        -   4. Hot melt adhesives        -   5. Contact adhesives    -   iv. Secondary operations        -   1. Heat Seal        -   2. Pierce

Several further embodiments are described below. More specificinformation regarding the tool 10 and a stretch membrane cover 12including upper member 12 a and lower member 12 b, of the FIG. 2embodiment is described below as follows:

a. This embodiment uses a rigid body mechanical housing 14 inconjunction with a highly stretchable membrane 12 (balloon like) tocover and protect the tool 10 from contamination by blood/bone/tissueduring a procedure. This cover 12 is a removable, single use cover ofcontamination blocking material. Single and multiple layerconfigurations can be considered for this version. Single or multiplemembranes may be used to protect various areas of the tool 10 (main bodyvs. battery pack allowing access to battery pack at the start of aprocedure). Variable wall thickness or reinforcements can be used inhigh stress areas. Members 12 a and 12 b are stretched over housing 14and combined to form cover 12. Tool 10 is shown at 10 a prior toapplication of cover 12, and is shown at 10 b after the application ofcover 12.

-   -   i. Flexible membranes can be produced using blow molding, dip        molding, thermoforming, or other processes. Members 12 a and 12        b are stretched over housing 14 and combined to form cover 12.        Tool 10 is shown at 10 a prior to application of cover 12, and        is shown at 10 b after the application of cover 12.        -   1. Materials and alloys of these materials appropriate for            this concept include but are not limited to:            -   a. Silicone            -   b. Latex Rubber            -   c. Synthetic Rubber            -   d. Polychloroprene            -   e. Flexible PVC

b. Methods appropriate for applying the membrane around the outer shellinclude but are not limited to:

-   -   i. Stretching:        -   1. Manually        -   2. Automated        -   3. Individual sections (i.e. main body separate from Battery            Pack area)    -   ii. Secondary operation:        -   1. Additional seals/retention elements at operation            interfaces such as drill chuck or saw adaptor        -   2. Additional tape reinforcements in high stress areas

More specific information regarding the tool 10 and a shrink wrap cover12, FIGS. 3a, 3b , is described below as follows:

a. This embodiment uses a rigid body mechanical housing 14 inconjunction with a secondary shrink-wrap element 12 to cover and protectthe device from contamination by blood/bone/tissue during a procedure.Cover 12 is a removable, single-use cover of contamination blockingmaterial. Single and multiple layer configurations can be considered forthis version (see considerations for transport as non-biohazard state).Single or multiple wraps may be used to protect various areas of thetool 10 (main body vs. battery pack allowing access to battery pack atthe start of a procedure). Additional reinforcements or seals can beused in high stress areas. Shrink methods can include both heatapplication or a chilling operation depending on the type of shrink wraputilized. Tool 10 is shown at 10 a prior to application of cover 12, andis shown at 10 b after the application of cover 12 and shrinkactivation, FIGS. 3a , 3 b.

-   -   i. Flexible shrink-wrap can be produced using extrusion        processes, and are available in tape, FIG. 3a , sheet or tube        form, FIG. 3b and can be either heat or cold activated to create        the wrap required for device isolation. Some tape applications        carry an adhesive layer. The shrink-wrap tube cover 12 x, FIG.        3b , is trimmed at 12 y after shrink activation at 12 z.        Shrink-wrap tape, FIG. 3a is shown prior to wrapping at 12 x and        after wrapping and shrink activation at 12 y.        -   1. Materials and alloys/laminates of these materials            appropriate for this concept include but are not limited to:            -   a. Acetate            -   b. Polyethylene            -   c. PVC            -   d. Polyester            -   e. Polyolefin            -   f. Polypropylene

b. Methods appropriate for applying the membrane around the outer shellinclude but are not limited to:

-   -   i. Tape Wrapping:        -   1. Manually        -   2. Automated        -   3. Individual sections (i.e. main body separate from Battery            Pack area)    -   ii. Film Wrap:        -   1. Manually        -   2. Automated        -   3. Individual sections (i.e. main body separate from Battery            Pack area)    -   iii. Secondary operations:        -   1. Heat seal for complex geometries        -   2. Shrink Tunnel        -   3. Heat Gun        -   4. Refrigeration        -   5. Additional tape reinforcements in high stress areas        -   6. Adhesive application to tape wrap

In FIG. 4, an embodiment utilizes no traditional housing 14, asdescribed above, but provides the inner frame and working parts as tool110 and the outer hard shell cover 12 of tool 110 is provided as adisposable cover, as described below:

a. This embodiment uses a rigid sub-frame 110 carrying all mechanicalcomponents. The hard shell cover 12 has minimal mechanical content andis used as a disposable single-use housing of a contamination blockingmaterial to protect the mechanical components from contamination byblood/bone/tissue during a procedure. Cover 12 comprises cover portions12 a, 12 b. The sub-frame and mechanical components are intended formultiple re-use. This configuration may also be used in conjunction witha soft/flexible outer shell allowing for return of the device in anon-biohazard state. Combinations of materials such as hard shell withflexible inserted areas for controls actuation are also contained inthis area. Additional reinforcements or seals can be used in areassubject to contaminant intrusion. Thus, the hard shell, single-usedisposable cover 12 functions as a combination previously provided by atraditional housing 14 and cover 12.

-   -   i. Hard outer shell can be produced using injection molding,        thermoforming, or other processes.        -   I. Materials and alloys/laminates of these materials            appropriate for this concept include but are not limited to:            -   a. PETG & A/PET            -   b. Polystyrene            -   c. Acrylic            -   d. Polycarbonate            -   e. ABS            -   f. Nylon            -   g. Polyolefin            -   h. Polyetheretherketone PEEK            -   i. Polyetherimide PEI            -   j. Polyetersulfone PES            -   k. Polyvinylidene PVDF            -   l. Polymethylpentene PMP            -   m. Polysulfone PSO            -   n. Ethylene-chlorotrifluoroethylene ECTFE            -   o. Metals

b. Methods appropriate for fastening the outer shell to/around the innerstructure include but are no limited to:

-   -   i. Fasteners such as:        -   1. Screws        -   2. Rivets        -   3. Bolts    -   ii. Molded features such as:        -   1. Clips        -   2. Press fits        -   3. Slip fits    -   iii. Secondary operation:        -   1. Tape        -   2. Glue        -   3. Pressure sensitive adhesive        -   4. Hot melt adhesives        -   5. Contact adhesives        -   6. Heat seal        -   7. Pierce

In FIG. 5, another embodiment includes a tool 10 having a protectivespray cover 12 further described as follows:

a. This embodiment uses a rigid body mechanical housing 14 inconjunction with a secondary spray-on protective layer 12 to cover andprotect the tool 10 from contamination by blood/bone/tissue during aprocedure. Single and multiple layer configurations can be consideredfor this version by using a release layer between subsequent sprayapplications. This configuration may be used in conjunction withpreviously described protection systems to allow access to power sourceportion 18 at the start of a procedure. Additional reinforcements orseals can be used in areas subject to contaminant intrusion. Layer 12 isa removable, single-use cover of contamination blocking material.

-   -   i. Spray on protective layers can be applied either manually or        automatically. Specific areas not to be coated can be masked to        ensure correct device function. It may also be desirable to coat        individual components prior to assembly to minimize masking        issues.        -   1. Materials and alloys/laminates of these materials            appropriate for this concept include but are not limited to:            -   a. Natural rubber            -   b. Synthetic rubber            -   c. Polyurethane            -   d. Acrylic            -   e. Polyethylene            -   f. PVC            -   g. Polyester            -   h. Polyolefin            -   i. Polypropylene

b. Methods appropriate for applying the membrane around the outer shellinclude but are not limited to:

-   -   i. Aerosol application:        -   1. Manually        -   2. Automated        -   3. Individual section (i.e. main body separate from Battery            Pack area)    -   ii. Secondary operations:        -   I. Drying/curing

In FIG. 6, another embodiment includes a tool 10 having a protective diplayer as a cover 12 further described as follows:

a. This embodiment uses a rigid body mechanical housing in conjunctionwith a secondary dipping operation to apply a protective layer 12intended to cover and protect the tool 10 from contamination byblood/bone/tissue during a procedure. Single and multiple layerconfigurations can be considered for this version by using a releaselayer between subsequent dip applications. This configuration may beused in conjunction with previously described protection systems toallow access to power source portion 18 at the start of a procedure.Additional reinforcements or seals can be used in areas subject tocontaminant intrusion. Layer 12 is a removable, single-use cover ofcontamination blocking material.

-   -   i. Dip protective layers can be applied either manually or        automatically. Specific areas not to be coated can be masked to        ensure correct device function.        -   1. Materials and alloys/laminates of these materials            appropriate for this concept include but are not limited to:            -   a. Natural rubber            -   b. Synthetic rubber            -   c. Polyurethane            -   d. Acrylic            -   e. Polyethylene            -   f. PVC            -   g. Polyester            -   h. Polyolefin            -   i. Polypropylene

b. Methods appropriate for applying the membrane around the outer shellinclude but are not limited to:

-   -   i. Dip application:        -   1. Manually        -   2. Automated        -   3. Individual sections (i.e. main body separate from Battery            Pack area)        -   4. Secondary operations drying/curing

In FIG. 7, another embodiment includes a tool 10 with battery door 19providing access to power source portion 18 and having a protectiveheader bag formed to shape as a cover 12 further described as follows:

a. This embodiment uses a rigid body mechanical housing 14 inconjunction with a formed header bag outer shielding cover 12 thatprotects the majority of the tool 10 from contamination byblood/bone/tissue during a procedure. Additional reinforcements or sealscan be used in high stress areas. Header bag cover 12 comprises aremovable, single-use cover of contamination blocking material.

-   -   i. Header bag cover 12 can be produced using an extrusion        process for the base material with secondary forming and sealing        operations to create a sealed enclosure. The header bag 12 is a        shaped, non-stretchable, bag-like shell loosely fitted over the        housing 14.        -   1. Materials and alloys of these materials appropriate for            this concept include but are not limited to:            -   a. Synthetic paper            -   b. C-Flex            -   c. Flexible PVC            -   d. Polycarbonate            -   e. Polyester            -   f. Polyethylene            -   g. Polypropylene            -   h. Nylon            -   i. Polyolefin

b. Methods appropriate for fastening the header bag to/around the innerstructure include but are not limited to:

-   -   i. Adhesive in multiple forms        -   1. Tape        -   2. Glue        -   3. Pressure sensitive adhesive        -   4. Hot melt adhesives        -   5. Contact adhesives

In FIG. 8, another embodiment includes a tool 10 having a protective diecut wrap as a cover 12 further described as follows:

a. This embodiment uses a rigid body mechanical housing 14 inconjunction with a Precut Wrap outer shielding cover 12 that onceapplied protects the majority of the tool 10 from contamination byblood/bone/tissue during a procedure. Additional reinforcements or sealscan be used in high stress areas or areas vulnerable to contaminantintrusion.

-   -   i. The device can be produced using an extrusion process for the        base material with secondary cutting operations and sealing        components added to provide a method for creating a sealed        enclosure.        -   1. Materials and alloys of these materials appropriate for            this concept include but are not limited to:            -   a. Synthetic paper            -   b. C-Flex            -   c. Flexible PCV            -   d. Polycarbonate            -   e. Polyester            -   f. Polyethylene            -   g. Polypropylene            -   h. Nylon            -   i. Polyolefin

b. Methods for cutting the wrap to conform to the device include but arenot limited to:

-   -   i. Manual cutting    -   ii. Die cutting    -   iii. Rotary cutting

c. Methods appropriate for securing the wrap to/around the deviceinclude but are not limited to:

-   -   i. Creation of appropriate flattened geometry that once wrapped        conforms to the geometry of the device.    -   ii. Adhesive in multiple forms:        -   1. Tape        -   2. Glue        -   3. Pressure sensitive adhesive        -   4. Hot melt adhesives        -   5. Contact adhesives

In FIG. 9, similar to FIG. 2, another embodiment discloses a power tool10 including a first inner stretch membrane cover 112 and a second outerstretch membrane cover 212. This embodiment adds the outer cover 212 sothat after use of the tool 10, the outer cover 212 is removed and theinner membrane 112 stays in place on the tool 10. This embodimentenables shipping the used tool to a re-processor so as to avoid shippinga biohazard product. This embodiment is further described as follows:

a. This embodiment uses a rigid body mechanical housing 14 inconjunction with a two layer soft/flexible shell outer cover 112 and 212that protects the majority of the device from contamination byblood/bone/tissue during a procedure. Following the procedure and beforereturn shipment of the device the outermost contaminated cover 212 isremoved presenting the inner cover 112 that is a non-biohazard productand can economically be returned for re-processing.

In FIG. 10, tool housing 14, including tool attachment portion 20,handle portion 16 and power source portion 18 are illustrated from abackside perspective. The power source portion 18, as stated above maybe closed by the sealable door 19, shown removed. A cavity 25 in powersource portion 18 may receive a battery on-site when the sterilized toolis being made ready for use. When sterilized, cavity 25 is exposed dueto door 19 being removed and thus, the interior or cavity 25 of thepower source portion 18 is also sterile. In FIG. 11, door 19 isillustrated in attachment with power source portion 18, therebysealingly closing cavity 25. Also, a rear cannulation opening 23, FIGS.10 and 11, not required for saw blade attachment tools, is shown on abackside wall or surface of tool attachment portion 20 opposite a frontsidewall where chuck 21 is located. In this manner, a guide wire or pincan be fed through the tool attachment portion 20 via the cannulationopening 23 and exit via the chuck end for use with a cannulatedattachment. A seal 23 a, is provided to seal opening 23. The seal 23 amay be either a removable seal or a penetratable seal.

The limited use tool 10, FIG. 12, is returned to a re-supplier orre-processor to be prepared for re-use by packaging and sterilizing thetool. The single-use, contamination-blocking cover 12 is removed. Duringrepackaging, the tool 10 is placed in a partitioned tray 300 forshipping. Also, the removable, sealing access door 19 is placed in thetray 300 to be used after a battery is placed in a cavity within thepower source portion 18 on-site. The tray 300, containing the tool 10,access door 19 and a handle 305 available for two-handed operation(optional), are trayed and covered with a Tyvek lid or cover 310. Then aknown ETO sterilization process, or other suitable process, sterilizesthe contents of tray 300 in a gas chamber. Typically, a substantialnumber of the trayed tools are sterilized together for efficiency.Repackaged, sterilized trays 300 containing the tool 10 and access door19 are then shipped to the user. When used, a battery, stored at theuser's surgical facility is placed into the sterile cavity 25 in thepower portion 18. The sterile door 19 is then installed in the accessopening of cavity 25 (discussed above, see also FIG. 10).

The present disclosure has recognized and addressed many of theforegoing limitations and drawbacks of others concerning the need toprovide hospitals and surgery centers with an improved, more reliablesystem of cost-effective, battery-operated, motorized tools inconjunction with better cleaning and maintenance protocols. In practice,the disclosed tooling system utilizes a concept called limited-use tools(LUT) and specifically, a new cover or enclosure system to makereprocessing of the LUT more efficient. This cover or enclosure would beused only once in the operating room, then would be removed anddiscarded at the reprocessing facility. A new, single-use enclosurewould be installed at the reprocessing facility prior to final testing,packaging and re-sterilization of the LUT. The term “limited-use” asapplied to orthopedic surgical tools can mean having a limited usefullife, or a restricted lifespan for intended use. Preferably in thiscontext, limited-use is intended to mean the number of surgeries wherethe useful life of the tool ranges from more than one use to less than50 surgeries, and more preferably where the useful life of the toolranges from more than one use to less than 30 surgeries, and mostpreferably where the useful life of the tool ranges from more than oneuse to less than 20 surgeries.

In a broad respect this disclosure teaches a method of improving (i.e.reducing) potential risk factors associated with infection control, andreduction of potential disease and infection transmission due to lapsesin cleaning and infection control associated with routine maintenance ofreusable powered surgical instruments. In another broad respect, thedisclosure teaches a method of processing battery-operated tools used insurgery, to improve the cleanliness of instruments used in multiplesurgical procedures and reduce the potential for disease and infectiontransmission due to lapses in cleaning and infection control proceduresbetween procedures. In yet another broad respect, the disclosure teachesa method of logistical process of powered tools to improve cleanliness,operational efficiencies and performance. Still further it is to beunderstood that although this disclosure discusses the invention interms of battery operated tools, one skilled in the art would fullyappreciate that this disclosure has similar application to anypneumatic, wired or electric wall socket-powered instruments as well.

Although illustrative embodiments have been shown and described, a widerange of modification, change and substitution is contemplated in theforegoing disclosure and in some instances, some features of theembodiments may be employed without a corresponding use of otherfeatures. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the scope of theembodiments disclosed herein.

What is claimed is:
 1. A reusable medical procedure power toolcomprising: a tool sub-frame being rigid and including mechanicalcomponents of the tool; a cover mounted over the sub-frame, the coverbeing a single use, removable and disposable, contamination blockingcover including a tool attachment portion, a handle portion and a powersource portion; and at least the handle portion of the cover including aflexible portion providing a tactile feel portion for a user, thetactile feel portion being movable sufficient to move an associatedtrigger attached to the sub-frame.
 2. The tool of claim 1 wherein thetool attachment portion and the power source portion of the cover areformed of a rigid material.
 3. The tool of claim 1 wherein the toolattachment portion and the power source portion of the cover are formedof a flexible material.
 4. The tool of claim 1 wherein the handleportion of the cover includes a combination of a rigid materialincluding the flexible portion providing the tactile feel portion. 5.The tool of claim 1 wherein the cover is formed of multipleinterconnected portions.
 6. The tool of claim 1 wherein the cover isformed of a shaped stretch membrane.